Specimen removal device with gas venting

ABSTRACT

A removal pouch that is utilized for removing body tissue from the interior of the body as part of a minimally invasive surgical procedure. The specimen removal pouch includes an elongated body and a gas vent. The elongated body has an interior portion to collect specimen from a body cavity of a patient. The gas vent is configured to allow passage of gas from the interior portion of the elongated body to an external environment during removal of the pouch from within the body cavity of the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to, and the benefit of, U.S.Provisional Patent Application Ser. No. 61/451,755, filed Mar. 11, 2011,the entire contents of which are hereby incorporated by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to a specimen removal devicefor use during a surgical procedure, and more particularly, the presentdisclosure relates to a specimen removal device including a pouch havinga gas vent.

2. Description of Related Art

Laparoscopic and endoscopic surgical procedures are minimally invasiveprocedures in which operations are carried out within the body by usingelongated instruments inserted through small entrance openings orincisions in body tissue. The initial opening in the body tissue toallow passage of the endoscopic or laparoscopic instruments to theinterior portion of the body cavity may be a natural passageway of thebody, or it can be created by a tissue-piercing instrument, for example,but not limited to a trocar. Because the endoscopic or laparoscopiccannulae, instrumentation, and any required punctures or incisions arerelatively narrow, endoscopic or laparoscopic surgery is less invasiveas compared to conventional surgical procedures in which the surgeon isrequired to cut open large areas of body tissue. Therefore, laparoscopicor endoscopic surgery minimizes trauma to the patient and reducespatient recovery time.

Minimally invasive procedures may be used for partial or total removalof a body specimen, e.g., body tissue or organs, from an interiorportion of a body cavity, e.g. nephrectomy, cholecystectomy, and othersuch procedures. During such procedures, it is common that a cyst,tumor, tissue, foreign object or organ must be removed via the accessopening in the skin, or through a cannula. Various types of collectiondevices, for example, pouches or sacs, have been disclosed to facilitatethis procedure.

In certain situations, it is often difficult to remove a pouch or sacthrough a small laparoscopic incision and/or cannula when, in additionto the collected specimen, air is trapped therewithin. The trapped airincreases the volume of the pouch, thus, making the pouch large anddifficult to remove through a small opening, for example, a smallincision and a cannula. During removal, the enlarged pouch sometimestears or ruptures, which causes the collected specimen to spill insidethe abdominal cavity. The spilled specimen may sometimes causeinfection(s) or spreading of cancerous cells inside the abdominalcavity.

SUMMARY

Disclosed herein is a removal pouch that is utilized for removing bodytissue from the interior of the body as part of a minimally invasivesurgical procedure. The specimen removal pouch includes an elongatedbody and a gas vent. The elongated body has an interior portion tocollect specimen from a body cavity of a patient. A portion of theelongated body includes a gas vent that is configured to remove gas fromthe interior portion of the elongated body during removal of the pouchfrom within the body cavity of the patient.

In embodiments, the gas vent may include a hydrophobic material and/ormay be porous. The interior portion and an exterior portion of thespecimen removal pouch also may be coated with a lubricous material, forexample, a hydrogel.

In other embodiments, the gas vent may be positioned about the distalclosed end of the elongated body and/or may include one or more filterelements.

In other embodiments, the specimen removal pouch is utilized with aspecimen removal device for removing and confining tissue from asurrounding tissue in a body cavity during a surgical procedure. Thespecimen removal device includes an elongated tubular member, a pouch,and a drawstring. The elongated tubular member has an open distal endand a bore therein that is operably coupled to a housing. The housinghas a handle assembly that is operably coupled to a support member via adrive rod. The pouch is operably coupled to the support member andhaving an interior portion for receiving tissue from the body cavity. Asdescribed above, the pouch includes a gas vent and an elongated portionthat has a proximal open end and a distal open end. The gas vent has aproximal open end and a distal closed end. The gas vent is coupled tothe distal open end of the elongated portion and a portion of the gasvent includes a hydrophobic material for removing gas from the interiorportion of the pouch. The drawstring is operatively coupled to theproximal open end of the elongated portion wherein pulling thedrawstring in a proximal direction causes the pouch to move in aproximal direction and the proximal open end of the elongated portion tosubstantially close.

In embodiments, the support member may include a pair of resilientsupport portions such that each of the resilient support portions has afirst end attached to the drive rod.

In other embodiments, the device may include a locking tab that has alocking position that is in engagement with the drive rod and areleasing position that is disengaged from the drive rod. The handleassembly may also slidably support the locking tab.

These and other features of the current disclosure will be explained ingreater detail in the following detailed description of the variousembodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other aspects, features, and advantages of the presentdisclosure will become more apparent in light of the following detaileddescription when taken in conjunction with the accompanying drawings inwhich:

FIG. 1A is a perspective view of a specimen removal device including apouch according to the present disclosure shown in an undeployedconfiguration;

FIG. 1B is a perspective view of the specimen removal device of FIG. 1Aincluding an embodiment of a pouch according to the present disclosureshown in a deployed configuration;

FIG. 1C is a perspective view of the specimen removal device of FIG. 1Aincluding another embodiment of a pouch shown in a deployedconfiguration according to the present disclosure;

FIG. 2A is an enlarged view of the pouch of FIG. 1B according to thepresent disclosure;

FIG. 2B is an enlarged view of the pouch of FIG. 1C according to thepresent disclosure;

FIG. 3 is a side view of the pouch of FIG. 1B according to the presentdisclosure; and

FIGS. 4-7 illustrate removal of the pouch of FIG. 1B from a body cavityaccording to an embodiment of the present disclosure.

Other features of the present disclosure will become apparent from thefollowing detailed description, taken in conjunction with theaccompanying drawings, which illustrate, by way of example, theprinciples of the present disclosure.

DETAILED DESCRIPTION

Embodiments of the present disclosure will now be described in detailwith reference to the drawings, in which like reference numeralsdesignate identical or corresponding elements in each of the severalviews. As used herein, the term “distal” refers to the portion of theinstrument which is further from the user while, the term “proximal”refers to that portion of the instrument which is closer to the user. Asused herein, the phrase “external environment” refers to the areaoutside the instrument or any of the embodiments of the presentdisclosure. In the following description, well-known functions orconstructions are not described in detail to avoid obscuring the presentdisclosure in unnecessary detail.

As used herein with reference to the present disclosure, the terms“laparoscopic” and “endoscopic” are interchangeable and refer toinstruments having a relatively narrow operating portion for insertioninto a cannula or a small incision in the skin. They also refer tominimally invasive surgical procedures. It is believed that the presentdisclosure may find use in any procedure where access to the interior ofthe body is limited to a relatively small incision, with or without theuse of a cannula as in minimally invasive procedures.

Generally, the present disclosure is directed to a pouch made of anelastomeric membrane (e.g., thermoplastic polyurethane) that may be usedin conjunction with an endoscopic specimen removal device. Inembodiments, at least a portion of the pouch is made from a hydrophobicfilter material or element (e.g., polyolefin fibers), which allows thepouch to release or vent air that is trapped within an interior portionof the pouch to an external environment, while retaining fluid or othermatter (e.g., contaminated tissue) within the pouch. Further, thetrapped air is effectively vented from within the pouch to allow thepouch to decrease in size and facilitate removal through a smalllaparoscopic incision and/or cannula. The present disclosure alsoprovides a pouch including a lubricious coating on an inside and outsideportion the pouch material.

Referring now to the drawings, in which like reference numerals identifyidentical or substantially similar parts throughout the several views,FIGS. 1B and 1C illustrate a specimen removal devices 10 and 10′ thatare configured and dimensioned for use in minimally invasive surgicalprocedures (e.g. laparoscopic, endoscopic, and thoracic procedures). Asshown in FIG. 1B, specimen removal device 10 includes an embodiment of aremoval pouch 100, while FIG. 1C illustrates specimen removal device 10′with another embodiment of a removal pouch 200. A specimen removaldevice suitable for use in conjunction with either removal pouch isdisclosed in, commonly owned, U.S. Pat. No. 5,647,372 to Tovey et al.and in U.S. Pat. No. 5,465,731 to Bell et al. and the entire contents ofeach is hereby incorporated by reference in their entirety.

Referring now to FIG. 1A, specimen removal device 10 is shown in anundeployed configuration and includes an elongated tubular member 12, ahandle assembly 20, a drive rod 18 and a support member 30. Tubularmember 12 slidably houses drive rod 18 and support member 30, whichincludes resilient support portions 32 and 34. Elongated tubular member12 includes a proximal portion 14 and a distal portion 16. Proximal end14 of tubular member 12 engages handle assembly 20, which tubular member12 extends therefrom. Elongated tubular member 12 is configured anddimensioned for insertion through a small incision or a cannula 300(FIGS. 4-7) for endoscopic or laparoscopic procedures.

Handle assembly 20 includes handle portions 20 a and 20 b, a slidablefinger loop 22 and a finger loop 24, which are each configured forergonomically receiving fingers of a user. Handle assembly 20 alsoincludes a drawstring 26 that is partially disposed within tubularmember 12. Finger loop 24 is attached to one end of drawstring 26, asshown in FIGS. 1A-1C, while an opposing end of drawstring 26 is attachedto a pouch 100 (FIGS. 6 and 7). Support member 30 forms a resilientspring loop configuration when resilient support portions 32 and 34 areconnected. In the initial, unused or undeployed condition, pouch 100 isrolled up and the support member 30, including support portions 32 and34, is in a relatively straight configuration and positioned within adistal portion 16 of tubular member 12 (FIG. 1A). In the deployedcondition, pouch 100 is unfolded and connected support portions 32 and34 expand to a loop configuration that supports pouch 100 (FIG. 1B),which will be further described in detail below.

Still referring to FIG. 1A, a locking tab 28 may be provided to preventpremature actuation of the surgical removal apparatus 10 (e.g., duringshipping). Locking tab 28 is configured to engage a slot defined ondrive rod 18 in a snap-fit manner (not shown). In this configuration,drive rod 18 is prevented from being pushed distally when locking tab 28is engaged to drive rod 18 at a proximal end of handle portions 20 a and20 b of handle assembly 20. To actuate surgical removal apparatus 10,the user (e.g., a surgeon) disengages locking tab 28, by pulling lockingtab 28 off drive rod 18, and, subsequently, advances drive rod 18 in adistal direction, by pushing slidable finger loop 22 in a distaldirection. When drive rod 18 is advanced distally, support member 30 isalso advanced to a location distal than distal end 16 of tubular member12, and resiliently opens to the loop formation, which thereby deploysand opens pouch 100, 200 attached thereto (FIGS. 1B and 1C).

Referring now to FIG. 1B, specimen removal device 10 is shown in adeployed configuration. In this configuration, support member 30 is in adistally, extended and deployed loop configuration, which thereby openspouch 100 to an open configuration. Pouch 100 may be configured to haveany suitable dimension for the purpose of collecting or entrappingspecimen(s), for example, organ(s), tissue, and/or foreign objects fromwithin a body cavity of a patient. Pouch 100 includes an elongatedportion 110, an open proximal portion or mouth 106 and a closed distalportion 108. Elongated portion 110 is a flexible film or sheet formedfrom an elastomeric membrane, for example, but not limited tothermoplastic polyurethane (TPU). Elongated portion 110 may also beformed from a substantially transparent polymeric material, for example,but not limited to a polyurethane material. Additionally oralternatively, other biocompatible materials capable of forming aflexible membrane, such as latex, may be used. In embodiments, pouch 100may be formed from an aromatic polyester type thermoplasticpolyurethane. In addition, the material may be impervious to penetrationby cancer cells.

Referring to FIGS. 1B and 2A, in accordance with an embodiment of thepresent disclosure, distal portion 108 of pouch 100 includes a gas vent120 that is formed from a filter material. More specifically, a proximalend 122 of gas vent 120 is coupled to a distal end 112 of elongatedportion 110 at a bonding region 130. It should be noted that thepositioning of gas vent 120 is not limited to only the distal portion108 of pouch 100 and gas vent 120 may be positioned at any portion ofpouch 100. Gas vent 120 is made of a hydrophobic air filtering materialor membrane. Additionally, gas vent 120 may be a porous and durablematerial (e.g., polyolefin fibers). In this configuration, gas (e.g.,air) that is trapped within an interior portion of pouch 100 is released(e.g., venting) to an external environment (e.g., inside the bodycavity) via gas vent 120, while retaining a tissue “T” (FIG. 5-7) withinpouch 100. Further, when the trapped gas is effectively vented fromwithin pouch 100 to the external environment, the volume of pouch 100decreases to facilitate removal through a small laparoscopic incision orcannula 300 (FIGS. 4 and 6-8).

Additionally, a lubricious coating may be applied on the interiorportion and/or the exterior portion of pouch 100. In this manner, thelubricous coating will facilitate removal of pouch 100 by decreasingfriction between the exterior portion of pouch 100 and a smalllaparoscopic incision or cannula 300. Further, the lubricous coatingwill facilitate insertion of tissue “T” within the interior portion ofpouch 100. The lubricous coating may be, for example, but not limitedto, a hydrogel coating.

Referring now to FIG. 1C, specimen removal device 10′ is shown in adeployed state. In this configuration, support member 30 is in thedistally, extended and deployed loop configuration, which thereby openspouch 200 to an open configuration. Pouch 200 may be configured to haveany suitable dimension for the purpose of collecting or entrappingspecimen(s), for example, organ(s), tissue, and/or foreign objects fromwithin a body cavity of a patient. Similar to pouch 100, pouch 200includes an elongated portion 210, an open proximal portion or mouth 206and a closed distal end portion 208. Elongated portion 210 is a flexiblefilm or sheet formed from an elastomeric membrane, for example, but notlimited to thermoplastic polyurethane (TPU). Elongated portion 210 mayalso be formed from a substantially transparent polymeric material, forexample, but not limited to a polyurethane material. Additionally oralternatively, other biocompatible materials may be used to form theflexible membrane of pouch 200, for example, but not limited to latexand polyisoprene. In embodiments, pouch 200 may also be formed from anaromatic, polyester-type thermoplastic polyurethane. In addition, thepouch material may be impervious to penetration by cancer cells.

Referring to FIGS. 1C and 2B, in accordance with another embodiment ofthe present disclosure, elongated portion 210 is dimensioned to have adistal portion 220 towards the distal portion 208. It should be notedthat distal portion 220 may have any suitable shape (e.g., conical,round and square). Distal portion 220 includes one or more openings 224,which are each at least partially covered by a filter element 226. Morespecifically, filter element 226 overlaps opening 224 to adhere theretoat a bonding region 230. Similar to filter material used with gas vent120 (FIG. 1B), each of filter elements 226 is made from a hydrophobicair filtering material or membrane. Additionally, each of filterelements 226 may be a porous and durable material (e.g., polyolefinfibers). In this configuration, air that is trapped within an interiorportion of pouch 200 is released (e.g., venting) to an externalenvironment (e.g., inside the body cavity) via one or more filterelements 226, while retaining a tissue “T” (FIG. 5-7) within pouch 200.Further, when the trapped gas is effectively vented from within pouch200 to the external environment, the volume of pouch 200 decreases tofacilitate removal through a small laparoscopic incision or cannula 300(FIGS. 4 and 6-8).

For purposes of brevity, the attachment of the material used inconjunction with gas vent 120 and filter elements 226 to pouches 100(FIG. 1B) and 200 will be described together. As such, variousembodiments will be described, with regard to the attachment of thematerial used in conjunction with gas vent 120 and filter elements 226to elongated portion 110, 220. In a first attaching technique, whenelongated portion 110, 210 is made of a thermoplastic polyurethane(TPU), the material used in conjunction with gas vent 120 and filterelements 226 may be chemically attached to elongated portion 110, 210,respectively. More specifically, the TPU material of elongated portion110, 210 is liquefied by dissolving the TPU material in a solvent (e.g.,methylene chloride and tetrahydrofuran) such that the TPU material willact as a bonding compound. In this manner, the TPU material of elongatedportion 110, 120 liquefies and penetrates pores of the material used inconjunction with gas vent 120 and filter elements 226. Once the solventhas evaporated, the TPU material of elongated portion 110, 210 securelyattaches to the material used in conjunction with gas vent 120 andfilter elements 226 at bonding region 130, 230, respectively.

In another attaching technique, the material used in conjunction withgas vent 120 and filter elements 226 may be attached to elongatedportion 110, 210 at bonding region 130, 230 with the use of double-sidedadhesive tape or biocompatible acrylic adhesive. In another attachingtechnique, the material used in conjunction with gas vent 120 and filterelements 226 may be attached to elongated portion 110, 210 with the useof RF welding of the material used in conjunction with gas vent 120 andfilter elements 226 to elongated portion 110, 210 at bonding region 130,230, respectively.

Referring now to FIG. 3, in accordance to other embodiments of thepresent disclosure, pouch 100 includes a linear portion 107 weakened byperforation or scoring, which extends circumferentially around mouth 106of pouch 100 so that pouch 100 may be detachably released by pullingwith sufficient force on finger loop 24 during a surgical operation whena user desires to detach pouch 100 from support member 30. In thismanner, when finger loop 24 is pulled, drawstring 26 pulls off pouch 100along the linear portion and detachably releases pouch 100 from supportmember 30 simultaneously with closure of mouth 106. Additionally oralternatively, structures also can be utilized to detach pouch 100 fromsupport member 30, such as by pulling with a grasper or by cutting witha scissors.

Referring now to FIGS. 4-7, a method of using specimen retrieval devices10 and 10′ with the various embodiments of pouches 100 and 200 pouchwill be described herein. For purposes of brevity, only specimenretrieval device 10 and pouch 100 will be described in the methodindicated below. However, it should be noted that the aforementionedmethod may be used with any of the above-described specimen retrievaldevices 10 and 10′ along with any of the above-described pouches 100 and200.

FIG. 4 illustrates specimen retrieval device 10 being inserted within acannula 300 in a distal “A” direction. Specimen retrieval device 10 isshown in a deployed state such that pouch 100 is in an openconfiguration to allow insertion of tissue “T” therewithin. FIG. 4 alsoillustrates a cannula 310 inserted within a skin layer 400 having agrasping instrument 500 that may be used to facilitate unfolding ofpouch 100, placing specimen tissue “T” within pouch 100, or positioningpouch 100.

FIG. 5 illustrates pouch 100 having a specimen tissue “T” insertedtherewithin. Pouch 100 is shown in a closed configuration to allowremoval of pouch 100 from within a patient's body cavity “BC.” Asdescribed above, pouch 100 is closed by pulling on drawstring 26 in aproximal direction. Grasping instrument 500 may be used to facilitatemanipulation of pouch 100. One or more grasping instruments 500 may beutilized to grasp drawstring 26, pouch 100 and/or tissue “T” tofacilitate insertion of tissue “T” within pouch 100 and/or removal ofpouch 100 from within the body cavity “BC.”

FIG. 6 illustrates pouch 100 being pulled towards an incision “I” bypulling drawstring 26 in a proximal direction, indicated by arrow “B.”Prior to entering incision “I,” pouch 100 is shown having air trappedtherewithin the interior portion of pouch 100 and having a large width“W1.” FIG. 7 illustrates pouch 100 being pulled into incision “I,” whichforces the dimension of pouch 100 to change to a smaller width “W2” thanthe previous width “W1.” That is, when pouch 100 is pulled in a proximal“B” direction through a small opening (e.g., an incision “I”), the gasis vented out of pouch 100 through gas vent 120 in an outward “V”direction. In this configuration, the volume (e.g., width “W1”) of pouch100 is reduced when pulled through the incision “I” and/or an opening ofcannula 300 (FIG. 5), thus, eliminating unnecessary gas pressure. Inthis manner, the chance of tearing or bursting filled pouch 100 isreduced and specimen tissue “T” prevented from spilling within theinterior cavity of a patient during retrieval of pouch 100. Referringadditionally to FIGS. 2A, 2B, it should be noted that gas vent 120 andthe material used in conjunction with gas vent 120 and filter elements226 of pouch 200 is configured to allow unidirectional flow of gases.For example, gases may only flow out of pouches 100 and 200 and not intopouch 100 and 200.

The surgical procedure being performed, the physical characteristics ofthe tissue sample “T” (e.g., size, mass, and density), and the volume ofany liquids present in the pouch 100, 200 may be factors in determiningthe amount of gas that escapes through gas vent 120 and/or filterelements 226.

Although portions of the above disclosure discuss one embodiment of thedisclosed pouch, the features discussed are equally applicable to otherembodiments of the pouch disclosed herein.

While the above description contains many specifics, these specificsshould not be construed as limitations on the scope of the presentdisclosure, but merely as exemplifications of preferred embodimentsthereof. For example, any of the disclosed filter elements described inthe present disclosure may be positioned at any portion of the disclosedpouches. Those skilled in the art will envision many other possiblevariations that are within the scope and spirit of the presentdisclosure.

What is claimed is:
 1. A specimen removal pouch comprising: an elongatedbody including an interior portion, a proximal mouth, a proximalportion, and a distal portion, the proximal portion is made of a firstmaterial, the distal portion includes at least one filter, the at leastone filter having a different porosity than the first material; whereinthe proximal mouth is movable from an open configuration to facilitateentry of a specimen into the interior portion through the proximalmouth, toward a closed configuration to hinder the specimen from exitingthe interior portion through the proximal mouth.
 2. The specimen removalpouch according to claim 1, wherein the at least one filter includes ahydrophobic material.
 3. The specimen removal pouch according to claim1, wherein a distal-most end of the elongated body is made from thefirst material.
 4. The specimen removal pouch according to claim 1,wherein the interior portion of the elongated body and an exteriorportion of the elongated body are coated with a lubricous material. 5.The specimen removal pouch according to claim 1, wherein the at leastone filter forms a discontinuity in the elongated body.
 6. The specimenremoval pouch according to claim 1, wherein the at least one filterincludes a plurality of filters, and wherein at least two adjacentfilters of the plurality of filters are separated by a portion of thefirst material.
 7. The specimen removal pouch according to claim 6,wherein each filter of the plurality of filters extends through thedistal portion of the elongated body.
 8. The specimen removal pouchaccording to claim 1, wherein the at least one filter is configured toallow passage of gas from within the elongated body through the distalportion of the elongated body.
 9. The specimen removal pouch accordingto claim 1, wherein the first material is a sheet formed from amembrane.
 10. The specimen removal pouch according to claim 1, whereinthe first material is a film formed from a membrane.
 11. A specimenremoval pouch comprising: an elongated portion having a proximal end anda distal open end, the proximal end being movable from an openconfiguration to facilitate entry of a specimen at least partiallythrough an opening defined by the proximal end, toward a closedconfiguration to hinder the specimen from moving through the opening;and a filter coupled to the distal open end of the elongated portion,the filter having a different porosity than the elongated portion. 12.The specimen removal pouch of claim 11, wherein the filter includes ahydrophobic material.
 13. The specimen removal pouch according to claim11, wherein a proximal end of the filter is coupled to the distal openend of the elongated portion.
 14. The specimen removal pouch accordingto claim 11, wherein a distal-most portion of the filter extends fartherdistally than the distal open end of the elongated portion.